BEIJING, Aug. 1, 2023
/PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a
biopharmaceutical company focused on developing and commercializing
innovative therapeutics and pharmaceutical products, today
announced the execution of an Assignment Agreement (the
"Agreement") with Mundipharma International Corporation Limited
("MICL"), Mundipharma Medical Company ("MMCo"), and Acrotech
Biopharma Inc. ("Acrotech") for the commercialization of
FOLOTYN® (Pralatrexate) in the
People's Republic of China ("China").
FOLOTYN® (Pralatrexate) is a dihydrofolate reductase
inhibitor indicated for the treatment of patients with relapsed or
refractory peripheral T-cell lymphoma ("PTCL"). This product was
approved by both the US Food and Drug Administration ("FDA") and
China's National Medical Products
Administration (NMPA) for PTCL. Under the terms of the
Agreement, CASI will assume MICL's rights and obligations with
respect to the commercialization of FOLOTYN® in
China.
Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive
Officer, commented, "We are very pleased to add
FOLOTYN®, another unique and approved drug product to
our commercial portfolio. The licensing of FOLOTYN® is
consistent with the company's strategy to grow our hematological
malignancy therapeutic area franchise. We will leverage CASI's
existing sales and commercial team's established capabilities and
infrastructure to launch and commercialize
FOLOTYN®."
"CASI has proven and strong capability to commercialize
proprietary medications and are extremely pleased to broaden our
existing relationship with them. We look forward to this exciting
launch and bringing this novel medicine to PTCL patients in
China," said Dr. Ashish
Anvekar, President of Acrotech Biopharma.
About Mundipharma
Mundipharma is a global healthcare company with a presence
across Africa, Asia Pacific, Canada, Europe, Latin
America, and the Middle
East.
Mundipharma is dedicated to bringing innovative treatments to
patients in the areas of Pain Management, Infectious Disease and
Consumer Healthcare as well as other severe and debilitating
disease areas. Our guiding principles, centered around Integrity
and Patient-Centricity, are at the heart of everything we do. For
more information visit www.mundipharma.com.
About Acrotech Biopharma Inc.
Acrotech Biopharma Inc. was formed as a global platform to
commercialize innovative proprietary medications. The company aims
to launch scientifically advanced products to address unmet needs
and deliver value to patients as well as all healthcare
stakeholders. Acrotech aspires to be a patient focused, research
based organization that strives to launch treatments which are
accessible to patients that need them. To learn more about Acrotech
Biopharma, visit https://acrotechbiopharma.com.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its hematology oncology therapeutic focus as well as other areas of
unmet medical need. The Company intends to execute its plan to
become a leader by launching medicines in the Greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China. More
information on CASI is available at
www.casipharmaceuticals.com.
Forward-Looking Statements
This announcement contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," "confident" and similar statements. Among
other things, the business outlook and quotations from management
in this announcement, as well as the Company's strategic and
operational plans, contain forward-looking statements. The Company
may also make written or oral forward-looking statements in its
periodic reports to the U.S. Securities and Exchange Commission
(the "SEC"), in in its annual report to shareholders, in press
releases and other written materials and in oral statements made by
its officers, directors or employees to third parties. Statements
that are not historical facts, including statements about the
Company's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties. A number of factors could cause actual results to
differ materially from those contained in any forward-looking
statement, including but not limited to the following: the risk
that we may be unable to continue as a going concern as a result of
our inability to raise sufficient capital for our operational
needs; the possibility that we may be delisted from trading on The
Nasdaq Capital Market if we fail to satisfy applicable continued
listing standards; the volatility in the market price of our
ordinary shares; the risk of substantial dilution of existing
shareholders in future share issuances; the difficulty of executing
our business strategy on a global basis including China; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates or future
candidates; legal or regulatory developments in China that adversely affect our ability to
operate in China, our lack of
experience in manufacturing products and uncertainty about our
resources and capabilities to do so on a clinical or commercial
scale; risks relating to the commercialization, if any, of our
products and proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); our inability to predict when or if our product
candidates will be approved for marketing by the U.S. Food and Drug
Administration, European Medicines Agency, PRC National Medical
Products Administration, or other regulatory authorities; our
inability to enter into strategic partnerships for the development,
commercialization, manufacturing and distribution of our proposed
product candidates or future candidates; the risks relating to the
need for additional capital and the uncertainty of securing
additional funding on favorable terms; the risks associated with
our product candidates, and the risks associated with our other
early-stage products under development; the risk that result in
preclinical and clinical models are not necessarily indicative of
clinical results; uncertainties relating to preclinical and
clinical trials, including delays to the commencement of such
trials; our ability to protect our intellectual property rights;
the lack of success in the clinical development of any of our
products; and our dependence on third parties; the risks related to
our dependence on Juventas to conduct the clinical development of
CNCT19 and to partner with us to co-market CNCT19; risks related to
our dependence on Juventas to ensure the patent protection and
prosecution for CNCT19; risks relating to the commercialization, if
any, of our proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); risks relating to interests of our largest
shareholder and our Chairman and CEO that differ from our other
shareholders; and risks related to the development of a new
manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd.
Further information regarding these and other risks is included in
the Company's filings with the SEC. All information provided herein
is as of the date of this announcement, and the Company undertakes
no obligation to update any forward-looking statement, except as
required under applicable law.
FOLOTYN® is proprietary to
Acrotech Biopharma Inc and its affiliates.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals, Inc.